CompletedNot Applicable

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

United States, Japan1,149 participantsStarted 2015-04-30

Plain-language summary

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained. 2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. Exclusion Criteria: * N/A

What they're measuring

Adverse event (AE)

Timeframe: 3 years

Trial details

NCT IDNCT02921828

SponsorCelgene

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12-10

View on ClinicalTrials.gov More Multiple Myeloma trials